
Medipines Corporation
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MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly is an FDA 510(k)-cleared medical device (K180902) manufactured by Medipines Corporation. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 2019. Regulation: 8.

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